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Gastro-Oesophageal Reflux Treatment for Prolonged Gastro-oesophageal reflux treatment for prolonged non- specific cough in children and adults (Review) Chang AB, Lasserson TJ, Gaffney J, Connor FL, Garske LA This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2006, Issue 4 http://www.thecochranelibrary.com Gastro-oesophageal reflux treatment for prolonged non-specific cough in children and adults (Review) Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 2 BACKGROUND .................................... 2 OBJECTIVES ..................................... 3 METHODS ...................................... 3 RESULTS....................................... 6 Figure1. ..................................... 7 Figure2. ..................................... 8 Figure3. ..................................... 9 Figure4. ..................................... 10 Figure5. ..................................... 10 Figure6. ..................................... 11 Figure7. ..................................... 11 Figure8. ..................................... 12 DISCUSSION ..................................... 13 Figure9. ..................................... 15 AUTHORS’CONCLUSIONS . 15 ACKNOWLEDGEMENTS . 16 REFERENCES ..................................... 16 CHARACTERISTICSOFSTUDIES . 21 DATAANDANALYSES. 43 Analysis 1.1. Comparison 1 Thickened versus unthickened feeds (infants), Outcome 1 Subjects cured (of cough) at end of study. .................................... 44 Analysis 1.2. Comparison 1 Thickened versus unthickened feeds (infants), Outcome 2 Cough frequency. 44 Analysis 2.1. Comparison 2 PPI versus placebo (> 18 years), Outcome 1 Clinical failures (still coughing at end of trial or reportingperiod). ... ... ... ... ... ... ... ... ... ... .. 45 Analysis 2.2. Comparison 2 PPI versus placebo (> 18 years), Outcome 2 Mean cough score at end of trial (1st arm crossover/parallelgrouptrials). ...... 46 Analysis 2.3. Comparison 2 PPI versus placebo (> 18 years), Outcome 3 Change in cough scores (end-beginning of intervention - 1st arm crossover/parallel group trials). ................. 47 Analysis 2.4. Comparison 2 PPI versus placebo (> 18 years), Outcome 4 Change in cough scores (crossover studies; standardisedscale).. 48 Analysis 2.5. Comparison 2 PPI versus placebo (> 18 years), Outcome 5 Absolute cough scores (crossover studies, standardisedscale).. 48 Analysis 2.6. Comparison 2 PPI versus placebo (> 18 years), Outcome 6 Change in cough score after 4 weeks treatment (1st arm cross over/parallel group trials). ......... 49 Analysis 2.7. Comparison 2 PPI versus placebo (> 18 years), Outcome 7 Difference in cough scores at week 8 - week 4 (1st armcrossover/parallelgrouptrials). ....... 50 APPENDICES ..................................... 50 WHAT’SNEW..................................... 51 HISTORY....................................... 51 CONTRIBUTIONSOFAUTHORS . 52 DECLARATIONSOFINTEREST . 52 SOURCESOFSUPPORT . 52 INDEXTERMS .................................... 53 Gastro-oesophageal reflux treatment for prolonged non-specific cough in children and adults (Review) i Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Review] Gastro-oesophageal reflux treatment for prolonged non- specific cough in children and adults Anne B Chang1, Toby J Lasserson2, Justin Gaffney3, Frances L Connor4, Luke A Garske5 1Queensland Children’s Respiratory Centre and Queensland Children’s Medical Research Institute, Royal Children’s Hospital, Brisbane and Menzies School of Health Research, CDU, Darwin, Brisbane, Australia. 2Community Health Sciences, St George’s, University of London, London, UK. 3Respiratory Medicine, Royal Children’s Hospital, Brisbane, Australia. 4Gastroenterology, Royal Children’s Hospital, Brisbane, Australia. 5Respiratory Medicine, Princess Alexandra Hospital, Brisbane, Australia Contact address: Anne B Chang, Queensland Children’s Respiratory Centre and Queensland Children’s Medical Research Institute, Royal Children’s Hospital, Brisbane and Menzies School of Health Research, CDU, Darwin, Herston Road, Herston, Brisbane, Queensland, 4029, Australia. [email protected]. [email protected]. Editorial group: Cochrane Airways Group. Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 4, 2009. Review content assessed as up-to-date: 9 June 2009. Citation: Chang AB, Lasserson TJ, Gaffney J, Connor FL, Garske LA. Gastro-oesophageal reflux treatment for prolonged non-specific cough in children and adults. Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.: CD004823. DOI: 10.1002/14651858.CD004823.pub3. Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. ABSTRACT Background Gastroesophageal reflux disease (GORD) is said to be the causative factor in up to 41% of adults with chronic cough. However cough and GORD are common ailments and their co-existence by chance is high. Also cough can induce reflux episodes. Treatment for GORD includes conservative measures (diet manipulation), pharmaceutical therapy (motility or prokinetic agents, H2-antagonist and proton pump inhibitors (PPI)) and fundoplication. Objectives To evaluate the efficacy of GORD treatment on chronic cough in children and adults with GORD and prolonged cough that is not related to an underlying respiratory disease i.e. non-specific chronic cough. Search strategy We searched the Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Specialised Register, MEDLINE and EMBASE databases, review articles and reference lists of relevant articles. The date of last search was 24th April 2009. Selection criteria All randomised controlled trials (RCTs) on GORD treatment for cough in children and adults without primary lung disease. Data collection and analysis Two review authors independently assessed trial quality and extracted. Study authors were contacted for further information. Gastro-oesophageal reflux treatment for prolonged non-specific cough in children and adults (Review) 1 Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Main results Eighteen studies (5 paediatric, 13 adults) were included. None of the paediatric studies could be included in meta-analysis. In adults, analysis on use of H2 antagonist, motility agents and conservative treatment for GORD were not possible (from lack of data) and there were no controlled studies on fundoplication as an intervention. Nine adult studies comparing PPI (two to three months) to placebo were analysed for various outcomes in the meta-analysis. Enrolment of participants subjects for two studies were primarily from medical clinics and another eight studies were otolaryngology clinic patients or patients with laryngeal symptoms. Using “intention to treat”, pooled data from studies resulted in no significant difference between treatment and placebo in total resolution of cough, Odds Ratio 0.46 (95% confidence interval (CI) 0.19 to 1.15). Pooled data revealed no overall significant improvement in cough outcomes (end of trial or change in cough scores). Significant differences were only found in sensitivity analyses. A significant improvement in change of cough scores was found in end of intervention (two to three months) in those receiving PPI with a standardised mean difference of - 0.41 (95% CI -0.75 to -0.07) using generic inverse variance analysis on cross over trials. Two studies reported improvement in cough after five days to two weeks of treatment. Authors’ conclusions There is insufficient evidence to definitely conclude that GORD treatment with PPI is universally beneficial for cough associated with GORD in adults. The beneficial effect was only seen in sub-analysis. The optimal duration of such a trial of therapy to evaluate response could not be ascertained although two RCTs reported significant change by 2-weeks of therapy. Clinicians should be cognisant of a period (natural resolution with time) and placebo effect in studies that utilise cough as an outcome measure. Future paediatric and adult studies should be double blind, randomised controlled, parallel design, using treatments for at least two months, with validated subjective and objective cough outcomes and include ascertainment of time to respond as well as assessment of acid and/or non-acid reflux. PLAIN LANGUAGE SUMMARY Gastro-oesophageal reflux treatment for prolonged non-specific cough in children and adults Cough in association with GORD is common in adults with chronic cough. The objective of this review was to evaluate the effectiveness of GORD treatment in children and adults with GORD and prolonged cough that is not related to an underlying respiratory disease i.e. non-specific chronic cough. Thirteen studies fulfilled predetermined criteria but only six could be used in various components of the meta-analysis including data obtained from trialists. Limited data on children prohibited any meta-analysis. In adults with cough and GORD, no significant difference was found in clinical cure using proton pump inhibitors (PPI) for cough and GORD. Using other outcomes, there was also no significant differences between PPI and placebo. This review also highlights the large placebo and time period effect of treatment for chronic cough. In adults GORD treatment with PPI for cough associated with
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